November 21, 2008

An article published in the New York Times early last month documents the steps large drug companies have taken to suppress research showing their expensive new drugs to be worthless or dangerous, to suborn doctors, and to foist questionable studies on the spineless folk who supposedly "peer review" the research used to make drug policy decisions.

Citing testimony of experts involved in a trial involving Pfizer's mismarketing of Neurontin, the article reports,

Pfizer’s tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, “spinning” negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results.

In making the case that Pfizer's behavior was part of a larger pattern of deception by drug companies, the articles cites the way that Schering-Plough delayed the release of the results of the study that ended up showing that its new moneymaker, Vytorin, did not slow the growth of plaque in arteries. Also reported is this:

In April ... a group of academic doctors questioned the validity of drug industry research after finding that Merck had hired ghostwriters to produce scientific articles about Vioxx, then recruited prestigious doctors to serve as their official authors.

In regards to Pfizer's handling of Neurontin, the article describes company emails discussing how to delay publication of research showing that Neurontin was ineffective for diabetic neuropathic pain. To see how effective the company's strategy was you have only to note that:

Dr. Dickersin, the Johns Hopkins expert, said that of 21 studies she reviewed, five were positive and 16 negative, meaning they did not prove the drug was effective. Of the five positive studies, four were published in full journal articles, yet only six of the negative studies were published and, of those, two were published in abbreviated form.

By now Neurontin has been exposed for what it is--an ineffective drug whose side effects included a heightened incidence of suicide among those who took it. But the strategies the big drug companies used to market Neurontin are no different from those they are using to market the rest of their moneymaking drugs.

Every time you see a new study touted in the press that "proves" some very expensive new drug has immense benefits, you have to wonder how many studies were not published that found the same drug to be ineffective.

Every time you see a prestigious doctor praising a new drug, you have to wonder how much he is being paid by the maker of that drug to influence him to sing its praises. Even though journals now require that doctors and researchers disclose whether they have taken drug company money, they do not require that they disclose how much. In the disclosures now pulished at the end of research studies, the academic researcher whose conference lunch was paid for by a drug company is indistiguishable from the "opinion leader" who received half a million dollars for "consulting fees" or for putting his name on research studies actually conducted and written up by drug company employees.

And once the drug related research makes it to the newspaper, even the paltry disclosure you find in journals goes by the wayside, so you have no way of knowing if the doctor you see quoted in the paper or speaking with authority on TV news is a paid spokesman for the drug.

If you think law suits like the one described in the NYTimes article might remedy the situation, think again.There's a simple reason why drug companies will continue to pursue this kind of behavior. The original maker of Neurontin, Warner-Lambert, paid $430 Million in claims after some of its illegal marketing tricks came to light. But the drug had earned $3 billion a year until it lost patent protection. So that $430 million was just written off as part of the cost of doing business. The profits were large enough to leave room for many more law suit payments while this ineffective, dangerous drug still yielded the kinds of profits other companies can only dream about.

Which is why all new and highly profitable drugs are dangerous to you, the patient. Right now the drug that ranks number one for new prescriptions written for a non-psychiatric drug is Januvia. Januvia costs about $150 a month per person. Last year Merck was selling 100,000 prescriptions for Januvia a week. That's $60 million a month or $7.2 billion a year.

With that kind of profit piling up every year, and the certainty that it will be 5-10 years before any truly disturbing information comes to light about Januvia's real dangers (which I have written about about HERE)there's plenty of money to pay settlements to the hundreds of thousands of people who contracted unnecessary cancers. Dr. Goldstein estimates based on the number of prescriptions written and the published data about increased cancer incidence in people taking Januvia compared to placebo in the drug's approval trials that Januvia may be causing an additional 30,000 cancers a year.

But don't hold your breath waiting for research to discover this and other disturbing side effects of new drugs. The events of the past few years make it unlikely that such studies will ever be conducted. With what happened to Vioxx, Avandia and Vytorin after the companies who made them ran post-marketing studies intended to expand their use only to have these studies discover that the drugs were killing people or not doing what they claimed to do, no drug company executives is likely to commission large scale post-marketing studies again.

Instead, as is currently the case with how Merck is handling Januvia, they will simply point to the very small, short-term studies done as part of the effort of getting the drug approved and use the results from these studies--carefully spun--to support the argument that the drug is safe and effective.

If you don't study a highly profitable drug you won't find out anything bad about it that could damage its profitability. And since the only organizations funding large scale studies of drugs right now are drug companies, without their support, no large long-term large studies of the kind that uncover the real problems with these drugs will ever take place.

Bottom line: Over the past decades the drug companies have so polluted the environment surrounding the medical research about their drugs that it is very hard to know what the true benefits and dangerous side effects are for these drugs. The safest drugs are those that have been on the market long enough to have lost patent protection. Drug companies promoting new drugs will fund studies intended to find flaws with these older drugs so they can promote their newer drugs as alternatives.

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UPDATE LATER THE SAME DAY: Wow, no sooner do I post this but the New York Times comes up with the news "An influential psychiatrist who served as the host of public radio’s popular “The Infinite Mind” program earned at least $1.3 million between 2000 and 2007 giving marketing lectures for drug makers, income not mentioned on the program."

Sheesh. Doesen't it seem like when someone pays you $1.3 million to market its product and you keep it hidden, the appropriate word to describe the relationship isn't "ties," its "corruption."

Of the man who hired this drug pusher to host the radio show the NYTimes reports, " Mr. Lichtenstein said that he was unaware of Dr. Goodwin’s financial ties to drug makers and that he called Dr. Goodwin earlier this year 'and asked him point-blank if he was receiving funding from pharmaceutical companies, directly or indirectly, and the answer was, "No."'"

Not surprisingly, Dr. Frederick Goodwin, the psychiatrist in question, is reported to have heavily promoted the safety of psychiatric drugs for children though their safety is far from assured and they are widely believed by people NOT receiving millions from drug companies to be highly overprescribed.

The undisclosed financial relationship was uncovered by Senator Charles Grassley who has long been one of my favorite senators for his unrelenting work in unveiling drug company corruption.

So how much drug money has gone to Dr. Buse, Dr. Nathan, Dr. Nissen and the other high profile doctors who frequently comment on diabetes research? You won't know until Senator Grassley gets around to investigating and cross-checking their records.

7
comments:

I can only hope that with Henry Waxman unseating John Dingell as chairman of the powerful House Committee on Energy and Commerce, Congress recognizes the huge expense these drugs are consuming from Medicare and Medicaid and decides to require more complete disclosure (I won't hold my breath waiting for that to happen, but at least some slowdowns to big pharma's "business as usual" in the coming year!

(1) Physicians who accept any consideration from a drug company (other than free samples to distribute to their patients) should be banned from prescribing drugs from that company, as a clear conflict of interest, with the penalty being loss of their licence to practise.

(2) Total expenditures on medical research should be tilted away from private pharmaceutical companies (20 years ago I believe they accounted for 2/3 of expenditures, probably more now) to non-profit institutions focusing a broad spectrum of therapies, not just drug development.

I was admitted to hospital here in central England this am. I had a pounding headache, awful pain behind my eyes, feelings of absence and I was beginning to mix up my words. In fact this has been happening for ages. This morning felt different and I was convinced I was about to pass out and / or fit.

Alongside the unquenchable thirst, frequency of using the toilet and a general feeling of malaise I was told I was nearly comatose and my blood sugar level 25.6... apparently they get concerned around 10...

Incredibly I had been to the Doctor twice in the last three years convinced that I was diabetic only to be told I wasn't and that I needed to work less.... (!)

A contact lens consultation 3 months ago told me I had vessels growing behind my eyes - probably due to long term contact lens wear. It now seems from my research in a few hours I have long term retinoplathy....

I'm astonished and really quite angry that my absolutely obvious symptoms were not picked up... and the irony? I'm a personal injury solicitor!

Thanks Jenny. I'm subscribed to your RSS feed and looking around the net to get as much info as possible.

The treatment is woeful as you say. I was confirmed Type 2 today. I was given a handful of leaflets, told to not eat carbs or sweet stuff and asked to go again in a couple of weeks. My level was still 22.7, and I was give some tablets.

I haven't had any management, and I'm left to my own devices for the next fortnight. I've purchased a sugar level reader and doing as much research as I can on the net. I'm still feeling pretty yuck too.

Because it is now "ancient history", no one seems willing to take a long look back to see how we arrived at new rDNA formulations of "human insulin". The lies and manipulations that brought forth the first genetically-engineered, commercially marketed product provided the 'roadmap' for the current pharmaceutical marketing abuses we now witness.

Human insulin has now been replaced by 'new and better' analogs . . . each with patent protection. Till the product approaches patent expiration, patients are NOT told the truth about the side effects. When patent protection is nearing expiration, a 'new and better' product springs forth . . . along with the heretofore hidden list of shortcomings about the 'old' product.

Animal insulin was successfully replaced by describing it as 'foreign' and dirty. Human insulin--because it was not harvested from human pancreases, and because technology did not exist to determine whether or not it was EXACTLY like human insulin--was in all likelihood a misnomer. And today's analogs are neither 'human' nor 'insulin.' Since we obviously have failed to learn from history, it appears we must continually repeat our errors.

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I was diagnosed with diabetes in 1998. Since then I've kept my A1cs in the 5.0-6.0% range using the techniques you'll find explained at The main Blood Sugar 101 Web Site, where you'll also find extensive discussion of the peer-reviewed research that backs up the statements you read here.

I've also published two books on related subjects, Blood Sugar 101: What They Don't Tell You About Diabetes, which was an Amazon Diabetes bestseller for 3 years and Diet 101: The Truth About Low Carb Diets.